Evaluation of Safety and Tolerability of ATB-320 in Participants With Progressive or Metastatic Solid Tumors

NCT06933524 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: ATB-320-001A
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  Occurrence of dose limiting toxicity (DLT) will be assessed for the DLT Analysis Set for each cohort until Cycle 1 Day 28 (C1D28) and will be discussed by the Data Monitoring Committee (DMC).

  First dose to Cycle 1 Day 28 (each cycle is 28 days)

• Maximum Tolerated Dose (MTD)

  The highest dose (cohort) at which no more than one out of three to six participants in a cohort experience a dose limiting toxicity (DLT).

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (1)

• Safety

  At the end of each cycle (each cycle is 28 days) and up to 14 days from the last dose of ATB-320

Study Arms (1)

ATB-320

EXPERIMENTAL

Participants will receive ATB-320 in cycles. One cycle will consist of 4 weeks (28 days). The study will start with Cohort 1 and the progression to the next cohort will depend on the occurrence of dose limiting toxicity (DLT). The dosage regimen of the investigational product is as follows: Cohort 1: 1.0 mg/kg Cohort 2: 2.0 mg/kg Cohort 3: 4.0 mg/kg Cohort 4: 8.0 mg/kg

Drug: ATB-320

Interventions

ATB-320 DRUG

IV infusion

ATB-320

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years or older) at the time of screening
• Histologically confirmed solid tumor
• Participants must have failed standard therapy or cannot tolerate standard therapy.
• Participants must be able to provide tissue samples, either stored at the institution or obtained from a biopsy performed prior to administration of the investigational product, and have tumor that can be safely biopsied throughout the study.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Life expectancy of ≥ 12 weeks

You may not qualify if:

• Has received chemotherapy within 21 days prior to the first planned dose of the investigational product, or if less than 5 times the half-life of the chemotherapeutic has passed (whichever is shorter)
• Has received immunotherapy within 2 weeks of the first planned dose of investigational product
• Major surgery within 4 weeks prior to the first planned dose of the investigational product
• Previous malignant tumors, other than the target indication to be investigated in this study, within 3 years prior to screening (participants with locally malignant tumors such as basal cell carcinoma/squamous cell carcinoma of the skin, carcinoma in situ (cervix, breast), thyroid papillary carcinoma that have undergone potentially curative therapy are eligible to participate in the study.
• Current enrollment in any other clinical trial or has received another investigational product or medical device treatment within 28 days of first planned dose (participants who are undergoing safety follow-up phase of a clinical trial may participate if more than 28 days have passed since the last dose of the previous investigational product)
• Has received prior radiotherapy within 2 weeks of the first planned dose. Participants who have received palliative radiotherapy for non-central nervous system (CNS) disease within 2 weeks of first planned dose are allowed to participate after 1-week washout (participants must have recovered from any radiation-related toxicities, not require corticosteroid treatment, and without radiation pneumonitis)
• History of hypersensitivity to the active ingredients or excipients of the investigational product or other drugs

Sponsors & Collaborators

• Autotelicbio: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 design

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share